MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 3, 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	09/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: three peg patella 35mm cat# 200-02-35 / serial# (b)(4).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately 3 yrs postop the initial rtka, the (b)(6) y/o male patient presented with a ¿sore knee¿, the insitu patella was worn and a pe exchange was performed due to wear and the ps cam and the button on the underside of the insert had snapped off from the body of the insert and was floating around the knee.The poly after three years was delaminated and pitted.Patient was last known to be in stable condition following the event.The device will be returned.
Additional Manufacturer Narrative
After further review of additional information.(h3) the revision reported may have been the result of either excessive flexion between the femoral component and the ps post or axial rotation mismatch between the femoral component and the tibial components, likely leading to offset/asymmetrical contact between the femoral cam and the ps post, which appears to have precipitated the fracture of the insert.However, the appearance of the fractured post, fractured locking button, and delamination damage to the polyethylene is indicative of oxidative degradation.The insert was packaged in a non-conforming vacuum bag for 6.5 years prior to implantation which may have been a contributing factor to the oxidative degradation and damage.This cannot be confirmed as the devices were not available for evaluation and no x-rays were provided.The most probable root cause associated with the reported event of "prosthesis fracture¿ is associated with a partial or full-thickness crack in the device materials, either during implantation or sometime after.Do not use if broken device is a screw.Also, the most probable root cause associated with the reported event of "prosthesis wear¿ is associated with material damage to a surface, usually involving progressive loss or displacement of material, due to relative motion between that surface and a contacting substance or substances.Furthermore, the most probable root cause associated with the reported event of "instability¿ is associated with undesirable stability of the joint or implant construct.
Additional Manufacturer Narrative
After further review of additional information received the following sections d9, g3, g6, h2, h3, h6, h7 and h9 have been updated accordingly.(h3) the revision reported may have been the result of either excessive flexion between the femoral component and the ps post or axial rotation mismatch between the femoral component and the tibial components, likely leading to excessive shear loading between the femoral cam and the ps post, which appears to have precipitated fracture of the insert.However, the fractured post, fractured locking button, and delamination damage to the polyethylene are also indicative of oxidative degradation.The insert was packaged in a non-conforming vacuum bag for 6.5 years prior to implantation which may have been a contributing factor to the oxidative degradation and damage.The potential malalignment/joint instability cannot be confirmed because no x-rays were provided.The most probable root cause associated with the reported event of ¿prosthesis fracture¿ is associated with a partial or full-thickness crack in the device materials, either during implantation or sometime after.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported may have been the result of either excessive flexion between the femoral component and the ps post or axial rotation mismatch between the femoral component and the tibial components, likely leading to excessive shear loading between the femoral cam and the ps post, which appears to have precipitated fracture of the insert.However, the fractured post, fractured locking button, and delamination damage to the polyethylene are also indicative of oxidative degradation.The insert was packaged in a non-conforming vacuum bag for 6.5 years prior to implantation which may have been a contributing factor to the oxidative degradation and damage.The potential malalignment/joint instability cannot be confirmed because no x-rays were provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: PS TIBIAL INSERTS SZ 3, 15MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 12617327
• Report Number: 1038671-2021-00529
• Device Sequence Number: 11100290
• Product Code: JWH
• UDI-Device Identifier: 10885862048332
• UDI-Public: 10885862048332
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/23/2020
• Device Model Number: N/A
• Device Catalogue Number: 204-23-15
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2021
• Supplement Date Received by Manufacturer: 07/22/2022; 10/27/2023; 01/09/2025
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 08/20/2022; 11/21/2023; 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0019-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 90 KG